VERSA GRASP SINGLE-USE GRASPING FORCEPS

Additional Manufacturer Narrative

TO INVESTIGATE THE ROOT CAUSE OF THIS ADVERSE EVENT, WE CONDUCTED THE FOLLOWING INVESTIGATIONS: 1. EVENT-RELATED SAMPLES: THE EVENT-RELATED SAMPLE HAS NOT BEEN RETURNED YET, SO IT IS NOT POSSIBLE TO CONDUCT AN ASSESSMENT AT THIS STAGE. WE HAVE INITIATED AN EXTERNAL INVESTIGATION. THE CUSTOMER COMPLAINT QUESTIONNAIRE FORM HAS BEEN SENT TO THE CUSTOMER TO OBTAIN MORE INFORMATION. IN THE QUESTIONNAIRE, WE ASKED FOR MORE INFORMATION ABOUT THE EVENT-RELATED SAMPLE, SUCH AS VIDEOS AND PHOTOS TAKEN AT THE TIME OF THE EVENT, TO FACILITATE FURTHER ANALYSIS OF THE ROOT CAUSE. WE HAVE NOT RECEIVED A REPLY FROM THE CUSTOMER YET. IF THE CUSTOMER PROVIDES A RESPONSE, WE WILL PROMPTLY CONDUCT AN INVESTIGATION BASED ON THE CONTENT OF THE RESPONSE. 2. DEVICE HISTORY RECORD: BASED ON THE CUSTOMER'S COMPLAINT CONTENT, COMBINED WITH THE PRODUCT INFORMATION PROVIDED IN THE REPORT AND THE ON-SITE INVESTIGATION RESULTS, THE SPECIFICATION AND MODEL OF VERSAGRASP IS M0067802000, WITH THE BATCH NUMBER 2025092001, THE PRODUCTION DATE IS SEPTEMBER 20, 2025, AND THE QUANTITY IS (B)(4) PCS. AFTER VERIFYING THE RELEVANT RECORDS OF THE PURCHASE, PRODUCTION, AND INSPECTION OF THIS BATCH OF PRODUCTS, NO ABNORMAL SITUATIONS WERE FOUND. WE CONDUCTED A COMPREHENSIVE TENSILE LOAD TEST ON THE PRODUCT ACCORDING TO THE STANDARD OPERATING PROCEDURES (SOP), AND THE TEST RESULTS WERE NORMAL (SOP STANDARD: TENSILE FORCE 80N, HOLD FOR 5 SECONDS). THE CLAMPING FORCE OF THE PRODUCT WAS ALSO TESTED IN ACCORDANCE WITH THE STANDARD OPERATING PROCEDURE (SOP). THE TEST RESULTS WERE NORMAL (SOP STANDARD: HOLD A 0.5-KILOGRAM OBJECT AND MAINTAIN IT FOR 5 SECONDS; NO DETACHMENT OCCURRED DURING THIS PERIOD). AND BEFORE THE PRODUCT PACKAGING, CONDUCT 100% FULL INSPECTION OF THE APPEARANCE AND OPENING/CLOSING FLEXIBILITY OF THE CLAMP HEAD COMPONENT. THE PRODUCTION PROCESS HAS STRICT QUALITY CONTROL. THE PRODUCT IS REQUIRED TO WITHSTAND AN AXIAL STATIC TENSILE FORCE OF 80N WITHOUT BREAKAGE OR DETACHMENT; THE FIRST 3 AND LAST 3 PIECES OF EACH BATCH ARE INSPECTED FOR THIS PERFORMANCE. IN ADDITION, 100% OF THE PRODUCTS UNDERGO A 45N LOADING TEST DURING PRODUCTION, AND THE OPENING/CLOSING PERFORMANCE IS INSPECTED AFTER THE TEST, WITH NO DEFECTS FOUND SO FAR. THEREFORE, THE CONNECTION STRENGTH OF NORMALLY ASSEMBLED PRODUCTS IS SUFFICIENT, AND THE FUNDAMENTAL REASON HAS LITTLE CORRELATION WITH THE PRODUCTION AND ASSEMBLY PROCESS. THERE HAVE BEEN NO CHANGES TO THE TECHNICAL STANDARDS, SPECIFICATIONS, PRODUCTION PROCESSES, QUALITY PARAMETERS, ETC. OF THE MATERIALS IN THE PURCHASE INSPECTION RECORDS, AND THERE HAVE BEEN NO INSTANCES OF SUBSTITUTION OR SUPPLIER CHANGES. 3. INVESTIGATION OF RETENTION SAMPLES FROM THE SAME BATCH: TAKE 3 PRODUCTS FROM THE SAME BATCH AND CONDUCT PHYSICAL PERFORMANCE TESTS ON THEM. WE CARRIED OUT A COMPREHENSIVE INSPECTION OF THE TENSILE LOADING TEST FOR THE PRODUCTS ACCORDING TO THE STANDARD OPERATING PROCEDURES. THE TEST RESULTS WERE NORMAL (THE STANDARD OPERATING PROCEDURES REQUIRE A TENSILE FORCE OF 80 NEWTONS AND A HOLDING TIME OF 5 SECONDS). AT THE SAME TIME, A COMPREHENSIVE TEST WAS CONDUCTED ON THE CLAMPING FORCE OF THE PRODUCTS. THE TEST RESULTS WERE ALSO NORMAL (HOLD A 0.5-KILOGRAM OBJECT AND MAINTAIN IT FOR 5 SECONDS WITHOUT FALLING OFF). ROOT CAUSE ANALYSIS: ACCORDING TO THE INVESTIGATION AND SAMPLE ANALYSIS, WE SPECULATE THAT THE POSSIBLE CAUSE IS AS FOLLOWS: USING FORCEPS TO GRASP A METAL STENT TYPICALLY SUBJECTS THE JAW ASSEMBLY TO HIGHER MECHANICAL LOADS, WHICH MAY EXCEED THE DESIGN LIMITS. WHEN GRASPING THE METAL STENT, THE OPERATOR MAY APPLY EXCESSIVE FORCE, OR THE STENT MAY BECOME STUCK, LEADING TO INTERACTION BETWEEN THE JAW ASSEMBLY AND THE HIGHLY RIGID METAL STENT, WHICH MAY CONSEQUENTLY RESULT IN FRACTURE OF THE JAW ASSEMBLY.

Description of Event or Problem

A SINGLE-USE GRASPING FORCEPS TIP BROKE OFF DURING A CYSTOSCOPY\STENT REMOVAL PROCEDURE AND WAS FOUND IN THE PATIENT'S BLADDER. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED BY DR. USING A NON-DISPOSABLE GRASPER. THE DISPOSABLE GRASPER AND THE RETRIEVED BROKEN PIECE WERE SENT TO THE LAB FOR EXAMINATION ALONG WITH PRODUCT'S PACKAGING. PRODUCT REF NUMBER: M2267802000/LOT NUMBER: 2025092001. THE PATIENT EXPERIENCED NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS AS A RESULT OF THE EVENT, AS REPORTED BY THE REPORTING FACILITY.